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Weight loss therapy for clinical management of patients with some atherosclerotic diseases: a randomized clinical trial
Oshakbayev K, Dukenbayeva B, Otarbayev N, Togizbayeva G, Tabynbayev N, Gazaliyeva M, Idrisov A, Oshakbayev P
Nutrition Journal 2015 Nov 25;14(120):Epub
clinical trial
4/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The prevalence and burden of atherosclerotic (AS) diseases are increasing during the last twenty years. Some studies show a close relationship between overweight and AS, but influence on AS diseases of different weight loss methods are still studying. The purpose of the research was to study the effectiveness of a weight loss program in AS patients in randomized controlled trial, and to develop a conception of evolution of AS. METHODS: A randomized controlled prospective clinical trial including 97 people, from them 71 patients with various AS manifestations. Patients were divided in 2 subgroups for non-drug weight loss program, and conventional drug therapy. The weight loss program included calorie restriction with 100 to 150 kcal/day, fat-free vegetables, salt diet, and optimum physical activity. Statistical analysis was performed using SPSS for Windows version 17.0. RESULTS: The weight loss subgroup lost ranging between 7 to 20% from an initial weight (p = 0.016). Weight loss was achieved due to fatty mass reduction only (p = 0.005). Hemoglobin levels (p < 0.001), bone mineral density (p < 0.001), percentages of water (p = 0.006) and muscle masses (p = 0.0038) were increased in weight loss subgroup. Ejection fraction (p < 0.0001), systolic output (p < 0.0001) were increased in patients with coronary artery disease. The weight loss program led to a decrease in symptomatic drugs doses up to total abolition. A conception of AS was developed. CONCLUSIONS: The weight loss program treated the AS diseases; improved laboratory and instrumental parameters, decreased symptomatic drugs doses. AS development is a logical way of ontogenetic ageing of body fat. TRIAL INTERNATIONAL REGISTRATION: ClinicalTrials.gov NCT01700075. TRIAL NATIONAL REGISTRATION: State registration is number 0109RK000079, code is O.0475 at the National Center for Scientific and Technical Information of the Republic of Kazakhstan.

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